Sunday, 23 September 2012

What is an embryo?

I have taken some interest over the past few years in where the boundary of patentable inventions lies. This has mostly involved consideration of the word "technical" and what it means, which tends to get tiring after a while. It therefore makes a nice change to see something come along about a boundary of patentability that has nothing to do with computers or business methods (except perhaps in a very tangential way). This was a decision from the UK IPO in International Stem
Cell Corporation (BL O/316/12), which was published last month. Rather than section 1(2), which has been the subject of a vast number of decisions over the past few years at the IPO, this one related to the less well chartered backwaters of Schedule A2, paragraph 3 of which states:

The following are not patentable inventions:

(a) the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene;

(b) processes for cloning human beings;

(c) processes for modifying the germ line genetic identity of human beings;

(d) uses of human embryos for industrial or commercial purposes;

(e) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes;

(f) any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a micro-biological or other technical process or the product of such a process.

Two applications were filed in 2006, which were then published as GB2431411A and GB2440333A. The applications were both objected to by the UK IPO examiner under paragraph 3(d), other objections
relating to novelty, inventive step, clarity and support having been overcome.
The compliance period in each case had been extended in order to await the
decision of the CJEU in case C-34/10, OliverBrüstle v Greenpeace, the outcome of which had a direct bearing on the
remaining issue to be resolved (see the IPKat here for more on the Brüstle case).

Each application concerned methods of producing human stem
cells, in which parthenogenesis (illustrated on the figure to the right; more information is available here) was used to activate a human oocyte, i.e.
stimulating the oocyte to divide without having been fertilised by a human
sperm cell, resulting in what was termed a “parthenote” to distinguish it from
an embryo resulting from fertilisation. The first application related to the
production of human stem cells from such parthenotes, while the second related
to synthetic corneas derived from parthenotes. The issue to be decided was
whether the claimed methods, stem cell lines or resulting tissue constituted
use of human embryos for industrial or commercial purposes and were therefore
unpatentable under paragraph 3(d). Neither the Act nor Directive 98/44/EC, which Schedule A2 implemented, provided a
definition of what constituted an “embryo”. The examiner argued that the
parthenotes of the invention fell within the definition of “human embryo” in
light of the decision in Brüstle and also
the definition provided by Section 1
of the UK Human Fertilisation andEmbryology Act 2008. In Brüstle
the CJEU had held that "any
non-fertilised human ovum whose division and further development have been
stimulated by parthenogenesis constitute a 'human embyro' within the meaning of
Article 6(2)(c) of the Directive" (paragraph 38 of the judgment). The
hearing officer considered that on the face of it this statement gave clear and
unambiguous direction that the applications should be refused.

The applicant argued that, since the
parthenogenetically-activated human oocytes of the invention were not capable
of commencing the process of development of a human being, the CJEU's decision
was based on a flawed factual basis and should not be binding. In support of
this the applicant cited several documents as evidence that a parthenote could
never develop to term due to an inherent biological limitation. A set of
amended claims was filed to clarify that the stem cells were only derived from
parthenotes that could never overcome such limitations. The hearing officer accepted
that on the evidence presented, the parthenotes of the invention were incapable
of continued development and could never turn into a human being, but did not
accept that the CJEU was necessarily wrong in deciding the way it did based on
the observations put to it. The UK courts were entitled to disregard a finding
of fact made by the CJEU, as they did in Factortame
[2000] 1 AC 524 and Arsenal v Reed
[2003] EWCA Civ 969. The same principle would also apply to the UK IPO but, as
the lowest level of tribunal, the hearing officer considered that the greatest
of caution should be exercised before departing from any aspect of the CJEU's
decision. Noting the point made in Arsenal
v Reed that the operative part of a judgment from the CJEU should always be
interpreted in light of the preceding reasoning, the hearing officer considered
that the conclusion of the CJEU relating to non-fertilised human ova stimulated
by parthenogenesis should not be taken in isolation from the preceding
reasoning, which was that patent law should be applied so as to respect the
fundamental principles safeguarding the dignity and integrity of the person.
The concept of "human embryo" must therefore be understood in a wide
sense since parthenogenetically-activated human oocytes were capable of
commencing the process of development of a human being. A distinction was made by
the hearing officer between commencing and completing the process of
development, comparing this with a train entering a tunnel and going through to the other end. Even though the parthenotes of the invention were not capable of
completing the process (coming out of the tunnel), the CJEU did not make this distinction and did not take
on board comments by the advocate general on this point. The decision of the
CJEU on this point could not therefore be ignored. The hearing officer
concluded that the invention defined in each of the applications, whether
amended or not, defined methods and products that were excluded. The applications were refused.

Although, as the hearing officer noted in this case, on the face of it the CJEU judgment indicated that parthenotes should be considered to be human embryos in the same way that fertilised embryos would, the applicant's arguments do appear to raise an important question as to whether the CJEU was correct in finding this a matter of fact. There appears to be a serious question to be addressed as to whether the CJEU's judgment on this point is something that can be departed from by a national court if the facts of a particular case differ. I look forward to seeing what happens when this question is considered by the High Court, which it will be in due course (a notice of appeal was lodged at the Patents Court on 13 September).

5 comments:

The CJEU did not in its judgment say that the relevant cells needed to be totipotent to be considered embryos, and so the criterion of ability to develop into a human being is not necessarily relevant.

An excellent piece. You are spot on with this, Tufty. Both the Decision and the Opinion on which it is based, are founded upon mistaken facts. A particular example arises in relation to Article 5, which M.Bot (correctly in my judgment,- although he went very decidedly off the rails thereafter) used in order to interpret the expression, "human embryo". Article 5 specifically refers to the unpatentability of "the human body at the various stages of its formation and development". M.Bot, without taking any evidence, assumed that a fertilised cell was a human body. It isn't.

About Me

Tufty the Cat is the nom de chat of UK and European patent attorney David Pearce (LinkedIn profile). Anything written by Tufty should not be taken as constituting legal advice, and no responsibility is taken for anything you might do as a result.